| TOFACITINIB CITRATE |
212943 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET;ORAL |
EQ 10MG BASE |
No
|
No
|
2021/06/01
|
2021/06/01
|
AJANTA PHARMA LTD |
Discontinued |
| TOFACITINIB CITRATE |
212943 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET;ORAL |
EQ 10MG BASE |
No
|
No
|
2021/06/01
(TA)
|
2021/06/01
|
AJANTA PHARMA LTD |
Discontinued |
| TOFACITINIB CITRATE |
214264 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2021/08/19
|
2021/08/19
|
ZYDUS PHARMS |
Discontinued |
| TOFACITINIB CITRATE |
214264 |
002 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 22MG BASE |
No
|
No
|
2021/08/19
|
2021/08/19
|
ZYDUS PHARMS |
Discontinued |
| TOFACITINIB CITRATE |
209738 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET;ORAL |
EQ 5MG BASE |
No
|
No
|
2023/03/13
|
2023/03/13
|
MICRO LABS |
Discontinued |
| TOFACITINIB CITRATE |
209738 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET;ORAL |
EQ 5MG BASE |
No
|
No
|
2023/03/13
(TA)
|
2023/03/13
|
MICRO LABS |
Discontinued |
| TOFACITINIB CITRATE |
209829 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET;ORAL |
EQ 5MG BASE |
No
|
No
|
2023/03/14
|
2023/03/13
|
ZYDUS PHARMS |
Discontinued |
| TOFACITINIB CITRATE |
216878 |
001 |
ANDA |
TOFACITINIB CITRATE |
SOLUTION;ORAL |
EQ 1MG BASE/ML |
No
|
No
|
2023/09/25
|
2023/09/25
|
HIKMA |
Discontinued |
| TOFACITINIB CITRATE |
218462 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2024/06/03
|
2024/06/03
|
AUROBINDO PHARMA LTD |
Discontinued |
| TOFACITINIB CITRATE |
218668 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2024/12/16
|
2024/12/16
|
DEXCEL |
Discontinued |
| TOFACITINIB CITRATE |
218668 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2024/12/16
(TA)
|
2024/12/16
|
DEXCEL |
Discontinued |
| TOFACITINIB CITRATE |
218668 |
002 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
22MG |
No
|
No
|
2024/12/16
|
--
|
DEXCEL |
None (Tentative Approval) |
| TOFACITINIB CITRATE |
218668 |
002 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
22MG |
No
|
No
|
2024/12/16
(TA)
|
--
|
DEXCEL |
None (Tentative Approval) |
| TOFACITINIB CITRATE |
219542 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/08/19
|
2025/08/19
|
AJANTA PHARMA LTD |
Prescription |
| TOFACITINIB CITRATE |
219542 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/08/19
(TA)
|
2025/08/19
|
AJANTA PHARMA LTD |
Prescription |
| TOFACITINIB CITRATE |
216001 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/09/30
|
2025/09/30
|
SINOTHERAPEUTICS INC |
Prescription |
| TOFACITINIB CITRATE |
216001 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/09/30
(TA)
|
2025/09/30
|
SINOTHERAPEUTICS INC |
Prescription |
| TOFACITINIB CITRATE |
219442 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/11/17
|
2025/11/17
|
BIOCON PHARMA |
Prescription |
| TOFACITINIB CITRATE |
219442 |
001 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 11MG BASE |
No
|
No
|
2025/11/17
(TA)
|
2025/11/17
|
BIOCON PHARMA |
Prescription |
| TOFACITINIB CITRATE |
219442 |
002 |
ANDA |
TOFACITINIB CITRATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 22MG BASE |
No
|
No
|
2025/11/17
|
--
|
BIOCON PHARMA |
None (Tentative Approval) |